By MELISSA HEALY Los Angeles Times
Last modified: 2014-08-01T03:34:10Z
Published: Thursday, Jul. 31, 2014 - 1:00 am
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Read more here: http://www.sacbee.com/2014/07/31/6597538/medical-labs-to-get-new-fda-oversight.html#storylink=cpyThe Food & Drug Administration on Thursday announced it would step up its regulation of a class of lab tests that have been key in ushering in an era of personalized medicine - a step the agency has long considered against strong opposition by small labs. The FDA's proposal would tighten the agency's oversight of laboratory-developed tests, which are designed, manufactured and used within a single lab. Most of the tests that would now come under more stringent review are used by physicians and hospitals to help diagnose and treat patients, and they have been widely used to detect certain types of gene-based cancers and guide their treatment.
As medical practice has grown increasingly dependent on genomic analysis, many small or specialized labs have gotten into the business of devising diagnostic tests, tailoring them to the needs of specialized practices, and providing laboratory services to hospitals and physicians.
Read more here: http://www.sacbee.com/2014/07/31/6597538/medical-labs-to-get-new-fda-oversight.html#storylink=cpy
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